UM-CERSI Awards Inaugural Innovation Grants to UMD, UMB and FDA Collaborators

COLLEGE PARK and BALTIMORE, Md. - The University of Maryland Center of Excellence in Regulatory Science and Innovation (UM-CERSI) has made four Innovation Awards to support collaborative research projects that foster the development of regulatory science in the areas of medications and/or medical devices.

The four Innovation Awards support research for one year on:

(1) A novel anesthesia registry;
(2) Use of imaging to predict drug interactions;
(3) Techniques to initiate best safety practices in the area of autonomous ventilators for preterm neonatal patients;
(4) A new assay for viral diagnostics.

"These Innovation Awards reflect the great depth and scope of research at the University of Maryland, which has the potential to impact drug and device regulation with the added benefit of facilitating even greater scientific interactions between university and FDA staff," says Natalie D. Eddington, professor and dean of the School of Pharmacy.

UM-CERSI, formed in 2011 , is an FDA-sponsored center run jointly by the College Park and Baltimore campuses of the University of Maryland. The Center's mission is to foster the development of regulatory science - the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality and performance of FDA-regulated products.

"Combining the talented faculty researchers on our College Park and Baltimore campuses, the University of Maryland is uniquely positioned to assist the FDA in modernizing and improving the ways drugs and medical devices are reviewed and evaluated," says Vice President for Research at the University of Maryland, College Park, Patrick O'Shea. "Our new activities and joint efforts with colleagues at the FDA, as well as outreach to industry partners, will lead to groundbreaking advancements to help improve the lives of Americans."

"These partnerships represent a critical, necessary and creative investment - one that will benefit not just FDA and academia, but also American consumers and industry," adds FDA Chief Scientist Jesse L. Goodman. "The Centers of Excellence will create new scientific research, training and staff exchange opportunities for FDA and leading area institutions."

2012 Awardees

Thomas E. Grissom, MD,
Department of Anesthesiology
University of Maryland School of Medicine

Potential Application of a Novel National Perioperative Outcomes Registry in Support of Active Post-Marketing Surveillance
This project aims to assess the advantages of using a large, novel anesthesia registry in support of FDA-mandated, post-marketing surveillance programs for anesthetic drugs and medical devices.

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Jean-Pierre Raufman,MD ,
Division of Gastroenterology and Hepatology
University of Maryland School of Medicine

James Polli, PhD ,
Department of Pharmaceutical Sciences
University of Maryland School of Pharmacy

In conjunction with Lei Zhang, PhD, FDA Office of Clinical Pharmacology

Development of Imaging as a Tool for in vivo Drug-interaction Assessments
This project aims to use imaging to predict transporter-mediated drug-to-drug interactions.

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Benjamin Shapiro, PhD ,
Fischell Department of Bioengineering
University of Maryland, College Park,

In collaboration with Bahram Parvinian, M.Sc., FDA Center for Devices and Radiological Health

FDA Safety and Performance Assessment of Emerging Autonomous Neonatal Ventilators by State-of-the-Art Robust Analysis Methods
This projects aims to apply and develop use-control verification techniques, specifically robust analysis,to initiate best safety practices in the area of autonomous ventilators for preterm neonatal patients.

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Ian M. White, PhD ,
Fischell Department of Bioengineering,
University of Maryland, College Park

In collaboration with Indira Hewlett, PhD, FDA Division of Emerging and Transfusion Transmitted Diseases

Collaborative Evaluation of Emerging Plasmonic Technologies for Point-of-Care Diagnostics in Low-resource Settings
This project aims to develop a paper-based, surface enhanced Raman scattering (SERS) assay for viral diagnostics.